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Remote consent (sometimes referred to as “teleconsent”) is a method of obtaining informed consent using a paper or electronic consent form where the study team and participant are not in the same physical location during the consent process. Use the checklist here to make sure the basic required consent elements are included in your written or oral presentation of study information. The “consent process” describes who will obtain informed consent and from whom, and when, where and how the consent process will take place
It also involves an assessment by the consent designee that the person providing informed consent understands what is being asked of him/her. It is important to include the required elements of informed consent in the consent process On the jhm irb website, on the forms page, under consent forms, there is a form titled “documentation of physician consent”
The attached electronic consent form cannot be used to enroll subjects
It is only for your files The hard copy of the approval memo and stamped consent form, that can be used to enroll subjects, have been sent to your office. It is the policy of the organization that no one may involve a human being as a participant in research or in a clinical investigation unless the investigator has obtained irb approval and, when required by the irb, that person’s legally effective informed consent. “alteration or waiver of informed consent” means a departure from the traditional consent process
Generally speaking, that process includes a thoughtful and thorough discussion of the study with the subject and confirmation that the subject understands the study and will participate voluntarily. The organization requires that, unless the exceptions meeting federal regulations are documented and approved by the reviewing committee, participants must sign and date a research consent form before study intervention or procedures begin. When will the jhm irb require that new applications with written consent forms use the version 17 template New applications submitted on or after june 5, 2023 must ensure all written consent forms use the version 17 template.
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